The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula

Pancreas Neoplasm Clinical Trial

— NLR  

Official title:

The Neutrophil-to-Lymphocyte Ratio at Post-operative Day 3: a Simple Tool to Exclude Clinically Relevant Postoperative Pancreatic Fistula After Pancreatoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724551
• Other study ID #: NLR-IPC 2020-058
• Status: Completed
• Start date: June 1, 2012
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2021
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.

Description:

From January 1, 2012 to December 31, 2020, consecutive patients underwent PD performed at Institut Paoli-Calmettes for various pathologies. Data were entered prospectively into a clinical database (NCT02871336).

The cohort was split into 3 groups:

• a training cohort ;

• an internal validation cohort (Paoli Calmettes institute);

• an external validation cohort (Rennes Pontchaillou Hospital).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 648
• Est. completion date: February 28, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent pancreatoduodenectomy

Exclusion Criteria:

• Total pancreatectomy

• Enucleation

Related Conditions & MeSH terms

• Fistula
• Pancreas Neoplasm
• Pancreatic Fistula
• Pancreatic Neoplasms

Intervention

Procedure:
• pancreatoduodenectomy (PD)
A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinically relevant pancreatic fistula	Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition	at hospital discharge assessed up to 30 days
Secondary	Biological markers	Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula	Postoperative day one and three